USPTO Patents Application 10551504

COPY SUBMITTED IN IDS

*V PATENT COOPERATION TREATY

PCT

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

(Chapter II of the Patent Cooperation Treaty)

lPCTArticle36andRule70|

Applicant's or agent's file reference

C1-A0322P

FOR FURTHER ACTION

SeeFormPCT/IPEA/416

International application No.

Internationa) filing date (day/monthfyear)

Priority dale {day/monthfyear)

PCT/JP2004/018499

10.12.2004

12.12.2003

International Parent Classification (IPC) or national classification and IPC

C07K16/28, A61K39/395, C12N15/13, C12P21/08

Applicant

CHUGAI SEIYAKU KABUSHIKI KAISHA

2.
X

This report is the international preliminary examination report, established by this International Preliminary Examining Authority
under Article 35 and transmitted to the applicant according to Article 36.

Ths REPORT consists of a total of _5 sheets, including this cover sheet.

TWs report is also accompanied by ANNEXES, comprising:

a. I I (sent to the applicant and to the International Biiremi) a total of sheets, as follows:

□ sheets of the description, claims tod/or drawings which have been amended and are the basis for this report and/or
sheets containing rectifications authorized by this Authority (sec Rule 70.16 and Section 607 of the Administrative
Instructions).

sheets which supersede earlier sheets, but which this Authority considers contain an amendment that goes beyond
the disclosure in the international application as filed, as indicated in item 4 of Box No. 1 and Ihe Supplemental
Box.

□

□

(sent to the International Bureau only) a total of (indicate type and number of electronic earnest s»

. containing a sequence listing and/or tables

related thereto, in computer readable form only, as indicated in the Supplemental Box Relating to Sequence Listing (see
Section 802 of the Administrative Instructions).

This report contains indications relating to the following items:
Basis of the report
Priority

Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
Lack of unity of invention

Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial applicability:
citations and explanations supporting such statement

Certain documents cited

Certain defects in the international application

Certain observations on Ihe international application

Box No. I

□

Box No. II

□

Box No. Ill

□

Box No. IV

El

Box No. V

□

Box No. VI

□

Box No. VII

□

Box No. VIII

Date of si* mission of the demand

Date of completion of this report

Name and mailing address of the IPEA/JP

Facsimile No.

Authorized officer
Telephone No.

Form PCT/I PEA/409 (cover sheet) (January 2004)

COPY SUBMITTED IN IDS

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018499

Box No. I

Baas of the report

With regard to the language, this report is based on the international application in the language in which it was filed, unless otherwise
indicated under this item.

r~| Ttiireport is based on translations from the original language into the following ■
which is the language of a translation furnished for the purposes of;

CZ1 international search (Rule 12.3 and 23.1(b))

I I publication of the internal ional application (Rule 12.4)

I I international preliminary examination (Rule 55.2 and/or 55.3)

With regard to the elements of the international application, this report is bated on (replacement shetls which haw been furnished to the
receiving Office in response to an imitation under Article 14 are referred to in this report as "originally filed" uiul are not annexe,! to
this report):

□

the international application as originally filed/furni shed
the description:

pages

pages* ;

pages*

as originally filed/furnished

received by this Authority on
received by this Authority on

□

(he claims:

nos.

nos *

nos.*

nos.*

ai originally filed/furnished

as amended (together with any statement) under Article 19

received by this Authority on
received by this Authority on

□

the drawings:

sheets

sheets*

sheets*

as originally fileoYfurnished

received by this Authority on
received by this Authority on

□

a sequence listing and/or any related tablets) - see Supplemental Box Relating lo Sequence Listing.

The amendments have resulted in the cancellation of:
I I the description, pages

□ the claims, nos.

the drawings, sheets/rigs

the sequence listing (specify):

any tablets) related lo sequence listing (specify):

□ This report has been established as if (some of) the amendments annexed lo this report and listed below had not been made, since
they have been considered to go beyond the disclosure as filed, as indicated in the Supplemental Box (Rule 70.2(c)!.

I 1 the description, pages

the claims, nos.

| | the drawings, sheets/figs

CD the sequence listing (specify): .

I I any table(s> related to sequence listing (specify):

If item •! applies, some or all of those sheets may be marked "superseded. "

Form PCT/1 PEA/409 (Box No. I) (January 2004)

COPY SUBMITTED IN IDS

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

Irternational application No.

PCT/JP2004/018499

Box No. V Reasoned statement under Article 35(1) with regard to novelty, inventive step or Industrial applicability;

citations and explanations supporting such statement

I. Statement

Novelty (N)

Inventive aep(IS)

Claims
Claims

Claims

Claims 1-14

Industrial applicability (IAI claims 1 ~ 1 4
Claims

YES
NO

YES
NO

YES
NO

2. Citations and explanations (Rule 70.7)

Document 1: WO 02/33072 Al (Chugai Pharmaceutical Co.,

Ltd.) , 25 April 2002
Document 2: WO 0.2/33073 Al (Chugai Pharmaceutical Co.,

Ltd.), 25 April 2002

v The invention set forth in claims 1 to 14 does not
involve an inventive step in the light of documents 1 and
2 cited in the international search report.

Documents 1 and 2 set forth a modified antibody
having an L chain V domain and an H chain V domain which
forms the same antigen bonding domain as a new antibody
which effectively does not have a TPO agonist activity
and which bonds to a TPO receptor, as a modified antibody
having TPO agonist activity, and suggest that said
modified antibody includes antibodies having an agonist
effect (see document 1, page 5, lines 17 to 25; document
2, page 5, lines 6 to 15) .

Moreover, a modified antibody containing two or more
L chain V domains and two or more H chain V domains of a
new antibody such as sc(Fv) 2 was a known feature at the
priority date of this application (see, for example, J.
Immunol. Methods, 1999, Vol. 231 (No. 1-2), pages 177 to
189, WO 01/79494 Al, WO 01/66737 Al).

FormPCT/lPEA/409(BoxNo. V> (January 2004)

COPY SUBMITTED IN IDS

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018499

Box No. V Reasoned statement under A rtlde 35(2) with regard to novel ly, inventive step or industrial applicability;

stations and explanations supporting such statement

In the light of said suggestion of documents 1 and
2, it would be easy for a person skilled in the art to
conceive of measuring the bonding activity of sample
antibodies, selecting a new antibody having bonding
activity, using known genetic engineering techniques to
prepare modified antibodies having the pair of H chain V
domain and L chain V domain of said new antibodies,
measuring the agonist activity of said modified
antibodies, and selecting a modified antibody having
agonist activity.

F«mPCTrtPEAM09(Bo!iNo.V> (January 2004)

COPY SUBMITTED IN IDS

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCI/JP2004/018499

Supplemental Box Relating lo Sequence Listing

Continuation of Box No. I, item 2:

I. With regard to any nucleotide and/or amino acid sequence disclosed in the international application and necessary to the claimed invention,
this report was established on Ihe basis of:

a- type of material

a sequence listing

□ lable(s) related lo Ihe xqven e listing
b. format of material

□ in written formal

£3 in computer readable form
c time of filirig/fiirnishing

IXI contained in the international application as filed

| 1 filed together with the international application in computer readable form

□ furnished subsequently to this AuJhority for the purposes of search anoVor examination

□ received by this Authority as an amendment* on

2. ] In addition, in Ihe case that more than one version or copy of a sequence listing and/ or table(s) relating thereto has been filed or

furnished, the required statements that the information in the subsequent or additional copies is identical to that in the application as
filed or does not go beyond the application as filed, as appropriate, were furnished.

3. Additional comments:

If item -1 in Box No. i applies, the listing aiid/or tablets) related thereto, which form part of the basis of the report, may be marked
"superseded "

Form PCT/IPEA/409 (Supplemental Box Relating to Sequence Listing) (January 2004)